Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.

<h4>Background</h4>Transparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and c...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Sabrina Tulka, Stephanie Knippschild, Sina Funck, Isabelle Goetjes, Yasmin Uluk, Christine Baulig
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/4eee9e82cc984651a3c39f8c24b48b59
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:4eee9e82cc984651a3c39f8c24b48b59
record_format	dspace
spelling	oai:doaj.org-article:4eee9e82cc984651a3c39f8c24b48b592021-12-02T20:11:02ZReporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.1932-620310.1371/journal.pone.0252640https://doaj.org/article/4eee9e82cc984651a3c39f8c24b48b592021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0252640https://doaj.org/toc/1932-6203<h4>Background</h4>Transparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and compare the reporting of statistical sample size calculations in RCT papers on the treatment of age-related macular degeneration (AMD), glaucoma and cataract published in 2018.<h4>Material and methods</h4>This study comprises a total of 113 RCT papers (RCT-P) published in 2018 (AMD: 14, glaucoma: 28, cataract: 71), in English or German, and identified through an internet-based literature search in PubMed and EMBASE. The primary outcome measure of the study was the number of trials providing a complete description of the underlying sample case calculation on the basis of the variables required (significance level, expected outcomes, power, and resulting sample size).<h4>Results</h4>Of the RCTs reviewed, 64% (AMD), 61% (glaucoma) and 31% (cataract) provided a justification of the number of patients included. A complete description of the described studies' sample size calculation including all the necessary values (primary outcome measure of this study) was described by 21% of the AMD, 29% of the cataract and 18% of the glaucoma RCT publications (in total: 24 of 113 (21%) at a confidence interval of 95%: [13%; 29%]).<h4>Conclusion</h4>All three treatment areas analysed lacked reporting quality regarding the justification of the number of patients included in a clinical trial based on a sample size calculation required for ethical reasons. More than half of all RCT publications reviewed did not provide all of the required information on statistical sample size calculation, and thus lacked transparency and completeness. It is therefore urgently required to involve methodologists in a study's planning and publishing processes to ensure that methodology descriptions are transparent and of high quality.Sabrina TulkaStephanie KnippschildSina FunckIsabelle GoetjesYasmin UlukChristine BauligPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0252640 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Sabrina Tulka Stephanie Knippschild Sina Funck Isabelle Goetjes Yasmin Uluk Christine Baulig Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
description	<h4>Background</h4>Transparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and compare the reporting of statistical sample size calculations in RCT papers on the treatment of age-related macular degeneration (AMD), glaucoma and cataract published in 2018.<h4>Material and methods</h4>This study comprises a total of 113 RCT papers (RCT-P) published in 2018 (AMD: 14, glaucoma: 28, cataract: 71), in English or German, and identified through an internet-based literature search in PubMed and EMBASE. The primary outcome measure of the study was the number of trials providing a complete description of the underlying sample case calculation on the basis of the variables required (significance level, expected outcomes, power, and resulting sample size).<h4>Results</h4>Of the RCTs reviewed, 64% (AMD), 61% (glaucoma) and 31% (cataract) provided a justification of the number of patients included. A complete description of the described studies' sample size calculation including all the necessary values (primary outcome measure of this study) was described by 21% of the AMD, 29% of the cataract and 18% of the glaucoma RCT publications (in total: 24 of 113 (21%) at a confidence interval of 95%: [13%; 29%]).<h4>Conclusion</h4>All three treatment areas analysed lacked reporting quality regarding the justification of the number of patients included in a clinical trial based on a sample size calculation required for ethical reasons. More than half of all RCT publications reviewed did not provide all of the required information on statistical sample size calculation, and thus lacked transparency and completeness. It is therefore urgently required to involve methodologists in a study's planning and publishing processes to ensure that methodology descriptions are transparent and of high quality.
format	article
author	Sabrina Tulka Stephanie Knippschild Sina Funck Isabelle Goetjes Yasmin Uluk Christine Baulig
author_facet	Sabrina Tulka Stephanie Knippschild Sina Funck Isabelle Goetjes Yasmin Uluk Christine Baulig
author_sort	Sabrina Tulka
title	Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
title_short	Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
title_full	Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
title_fullStr	Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
title_full_unstemmed	Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
title_sort	reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/4eee9e82cc984651a3c39f8c24b48b59
work_keys_str_mv	AT sabrinatulka reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract AT stephanieknippschild reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract AT sinafunck reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract AT isabellegoetjes reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract AT yasminuluk reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract AT christinebaulig reportingofstatisticalsamplesizecalculationsinpublicationsoftrialsonagerelatedmaculardegenerationglaucomaandcataract
_version_	1718374944115523584

Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.

Ejemplares similares